Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery

NCT03923556 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-2707
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two medications that reverse muscle paralysis at the end of kidney transplant surgery with the goal of reducing residual muscle weakness and insufficient respiratory function after surgery.

Conditions

Kidney Transplant; Complications; Postoperative Residual Curarization; Postoperative Residual Weakness

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)

  Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders

  Within up to 3 hours after the end of surgery

Secondary Outcomes (3)

• Number of Patients With Presence of qTOF <0.9 in PACU

  Within up to 3 hours after the end of surgery

• Number of Participants With Kidney Graft Dysfunction

  Within up to 3 postoperative days and at 14 +/- 3 days after surgery

• Rate of Adverse Events Related to NMBR Medications

  Within up to 3 postoperative days

Study Arms (2)

Sugammadex

EXPERIMENTAL

Sugammadex

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

Neostigmine

Drug: Neostigmine

Interventions

Sugammadex DRUG

Administration of Sugammadex intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 2-4 mg/kg) at the end of the surgery before tracheal extubation

Sugammadex

Neostigmine DRUG

Administration of Neostigmine intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 0.03-0.07 mg/kg) at the end of the surgery before tracheal extubation

Neostigmine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years or older
• Diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance \<30 mL/min)
• Planning on kidney transplantation surgery at the University of Colorado Hospital.

You may not qualify if:

• Patients unable to sign the informed consent
• Pregnant women
• Body Mass Index (BMI) \> 40 kg/m2
• Pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support)
• Patients with any pulmonary, neuromuscular or other disease that severely limits their respiratory functional status (e.g. unable to achieve 4 Metabolic Equivalent of Tasks, METs, such as climbing up 1 flight of stairs)
• Presence of any contraindication for any of the study-related medications or interventions.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr. Ana Fernandez-Bustamante
• Organization: University of Colorado School of Medicine

ana.fernandez-bustamante@cuanschutz.edu

720-848-6744

Study Officials

• Ana Fernandez-Bustamante, M.D., Ph.D.

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 22, 2019
• Study Start: February 2, 2021
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 22, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)